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Adverse Event Report

B.BRAUN MEDICAL BRAUN PERIFLY CONTINUOUS EPIDURAL ANESTHESIA TRAY   back to search results
Model Number CE 18TK
Event Description

Anesthesia medications won't flow through catheter. Catheter - radiopaque polyamide epidural catheter 20 ga closed tip.

 
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Brand NameBRAUN
Type of DevicePERIFLY CONTINUOUS EPIDURAL ANESTHESIA TRAY
Baseline Brand NamePERIFIX
Baseline Generic NameCONTINUOUS EPIDURAL KIT
Baseline Catalogue Number332220
Baseline Model NumberCE 18TK
Baseline Device FamilyCONTINUOUS EPIDURAL KITS
Baseline Device 510(K) NumberK840179
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed02/24/1984
Manufacturer (Section D)
B.BRAUN MEDICAL
bethlehem PA 18018
Device Event Key338771
MDR Report Key349471
Event Key329161
Report NumberMW1022721
Device Sequence Number1
Product CodeCAZ
Report Source Voluntary
Report Date 08/27/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/01/2002
Device MODEL NumberCE 18TK
Device LOT Number60188090
OTHER Device ID NumberREF 33220
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2001
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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